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Combination Chemotherapy in Treating Patients With Stage IIB, Stage III, or Stage IV Cancer of the Nasopharynx

Head and Neck Cancer Clinical Trial

Official title:
A Phase II Trial of Docetaxel, Cisplatin, 5-FU, and Leucovorin for Carcinoma of the Nasopharnyx

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IIB, stage III, or stage IV cancer of the nasopharynx.

Clinical Trial Description

OBJECTIVES: I. Determine the complete and overall response rate to docetaxel, cisplatin, fluorouracil, and leucovorin calcium in patients with potentially curable nasopharyngeal cancer. II. Assess the tolerability of this regimen in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour followed 1 hour later by cisplatin IV over 4 hours and fluorouracil IV and leucovorin calcium IV over 96 hours. Filgrastim (G-CSF) is administered subcutaneously beginning on day 5 and continuing until blood counts recover or day 10. Treatment repeats every 3 weeks for up to 3 courses. Within 2 weeks after the completion of chemotherapy, patients undergo definitive radiotherapy for about 7 weeks. After radiotherapy, patients who did not achieve complete remission after chemotherapy may undergo surgery. Patients are followed monthly for 1 year, then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004164
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 1999
View Details
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